At a glance
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Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
In Brief
A clinical study evaluating rotational atherectomy, cutting balloon, and 1 other intervention for Coronary Artery Disease and Atherosclerosis. Completed, enrolled 60 participants across 2 sites.
Detailed Summary
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
Study Details
Timeline
Interventions
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
current standard treatment of stent placement